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利培酮治疗品行障碍的双盲试点研究。

A double-blind pilot study of risperidone in the treatment of conduct disorder.

作者信息

Findling R L, McNamara N K, Branicky L A, Schluchter M D, Lemon E, Blumer J L

机构信息

Department of Psychiatry, Case Western Reserve University School of Medicine/University Hospitals of Cleveland, OH 44106-5080, USA.

出版信息

J Am Acad Child Adolesc Psychiatry. 2000 Apr;39(4):509-16. doi: 10.1097/00004583-200004000-00021.

Abstract

OBJECTIVE

To examine whether risperidone is superior to placebo in the treatment of youths with conduct disorder.

METHOD

This was a 10-week, randomized, double-blind, placebo-controlled study with 2 parallel arms. Ten youths were randomly assigned to receive placebo and 10 youths were randomly assigned to receive risperidone. Patients were seen weekly throughout the trial. Medications could be increased at weekly intervals during the first 6 weeks of the study from an initial dose of 0.25 mg or 0.50 mg each morning, depending on patient weight. Patients weighing less than 50 kg had a maximum total daily dose of risperidone of 1.5 mg. Patients weighing 50 kg or greater had a maximum total daily dose of risperidone of 3.0 mg. The primary outcome measure was the Rating of Aggression Against People and/or Property Scale.

RESULTS

Risperidone was superior to placebo in ameliorating aggression on most measures. Risperidone was reasonably well tolerated, with none of the risperidone-treated patients developing extrapyramidal side effects.

CONCLUSIONS

These data provide preliminary evidence that risperidone may have efficacy in the treatment of youths with conduct disorder. Because of the small sample size and the brief length of this study, further research is necessary to confirm these findings.

摘要

目的

探讨利培酮在治疗品行障碍青少年方面是否优于安慰剂。

方法

这是一项为期10周的随机、双盲、安慰剂对照研究,有2个平行组。10名青少年被随机分配接受安慰剂,10名青少年被随机分配接受利培酮。在整个试验过程中,每周对患者进行检查。在研究的前6周,根据患者体重,药物剂量可每周增加一次,初始剂量为每天早上0.25毫克或0.50毫克。体重小于50公斤的患者,利培酮的最大每日总剂量为1.5毫克。体重50公斤或以上的患者,利培酮的最大每日总剂量为3.0毫克。主要结局指标是针对人和/或财产的攻击行为评定量表。

结果

在大多数指标上,利培酮在改善攻击行为方面优于安慰剂。利培酮耐受性较好,接受利培酮治疗的患者均未出现锥体外系副作用。

结论

这些数据提供了初步证据,表明利培酮可能对治疗品行障碍青少年有效。由于本研究样本量小且时间短,需要进一步研究来证实这些发现。

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